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FDA Revises Process for Responding to Drug Applications

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Research
11 July 2008
The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved.
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The Doctor is In ... Your Inbox?

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Research
10 July 2008
Manhattan ResearchAccording to the latest physician study and advisory service released by Manhattan Research, approximately one-third of physicians are currently communicating with their patients online - a number which has grown over the past few years, but still lags behind consumer interest in communicating with physicians through the Internet.
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Internal body signals important for diabetes research

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Research
01 July 2008
A joint research project between Sweden and the USA has uncovered a so far unknown signal network involving the cells in the pancreas. This discovery has the potential to significantly revolutionise the treatment of diabetes. Diabetes has an enormous impact on the lives of families worldwide. Its impact can be measured both in economic terms and in terms of human lives. According to the World Health Organization (WHO), diabetes is expected to have caused 3.8 million deaths worldwide in 2007.
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Summary of responses on a legislative proposal to combat counterfeit medicines for human use

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Research
30 June 2008
ECIn response to the public consultation on "Key ideas for better protection of patients against the risk of counterfeit medicines", the Commission received 123 contributions from stakeholders. Of these, 100 were from industry (pharmaceutical industry, distributors, suppliers of active ingredients, consultants), 15 from citizens, patient (groups), and academics, and 8 from health professionals, pharmacists and health insurers.
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Information Technology Award Announced for Pharmacy in 2009

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Research
11 June 2008
First DataBank Europe (FDBE) in association with The Guild of Healthcare Pharmacists (GHP) and the UK Clinical Pharmacy Association (UKCPA) announced the 2009 FDBE/GHP/UKCPA Information Technology Award. The aim of the annual award, which is in its seventh year, is to encourage, support and promote information technology initiatives and best practice in the use of IT in hospital pharmacy.
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European Medicines Agency recommends measures to manage contamination of heparin-containing medicine

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Research
06 June 2008
The European Medicines AgencyThe European Medicines Agency has reviewed the risks associated with the use of heparin medicinal products contaminated with oversulphated chondroitin sulphate (OSCS). Heparins are used to prevent and treat blood clots. They are used widely in patients who could have, or have had a heart attack, in patients who have undergone major surgery, or patients on dialysis.
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New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

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Research
26 May 2008
U.S. Food and Drug Administration (FDA)HHS Secretary Mike Leavitt announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. "This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market," Secretary Leavitt said.
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More Pharma News ...

  1. Carbon nanotubes may cause cancer, study reveals
  2. UK parliament backs hybrid embryo research
  3. New Light on the Way Blood Vessels Grow
  4. Scientists identify molecule behind fat deposition and insulin release
  5. Scientists solve mystery of why arsenic works in cancer drugs
  6. Innovative Medicines Initiative to give boost to Europe's pharmaceutical industry
  7. Survey Takes Pulse of eHealth in Europe and Prescribes Wider ICT use Among Doctors
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Business & Industry

  • Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
  • Pfizer to acquire Global Blood Therapeutics for $5.4 billion to enhance presence in rare hematology
  • Roche's subcutaneous formulation of Tecentriq demonstrates positive Phase III results
  • Bayer Consumer Health leaders propose new principles for science-led self-care
  • GSK signs agreement to support pandemic preparedness in Europe

Research & Development

  • New method of nasal vaccine delivery could lead to better vaccines for HIV and COVID-19
  • Research identifies, exploits vulnerability in certain high-risk cancers
  • Scientists create long-acting injectable drug delivery system for tuberculosis
  • Treating cancer by sticking cells in place
  • Vitamin K prevents cell death: a new function for a long-known molecule
  • Disparities in United States COVID-19 vaccine distribution
  • New needle-free nasal vaccine shows promise for COVID-19

Conferences & Events

  • New approach to treatment of deadly kidney cancer
  • SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference

Regulatory Affairs

  • FDA approves first systemic treatment for alopecia areata
  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
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